combination chemotherapy in treating patients with solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase i trial to study the effectiveness of combining fenretinide, paclitaxel, and cisplatin in treating patients who have solid tumors that have not responded to previous therapy.

objectives: * determine the maximum tolerated dose, clinical toxicity, and recommended phase ii dose of fenretinide when combined with paclitaxel and cisplatin in patients with refractory solid tumors. * determine the pharmacokinetics of this regimen in these patients. * determine the therapeutic response to this regimen in these patients. outline: this is a dose escalation, multicenter study of fenretinide. patients receive oral fenretinide twice daily on days 1-7 and paclitaxel iv over 3 hours followed by cisplatin iv over 2 hours on day 2. on day 8 of course 1, patients also receive fenretinide once in the morning. treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. patients who achieve complete response receive 2 additional courses. cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. projected accrual: a total of 3-24 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: * histologically or cytologically proven refractory solid tumor for which paclitaxel and cisplatin are reasonable therapeutic options * no active cns disease * cns metastasis allowed if measurable disease outside of the cns and patient completed and recovered from 1 prior course of cns radiotherapy (if clinically indicated) patient characteristics: age: * 18 and over performance status: * ecog 0-2 or * zubrod 0-2 life expectancy: * not specified hematopoietic: * platelet count at least 100,000/mm3 * absolute neutrophil count at least 1,500/mm3 hepatic: * bilirubin no greater than 2.0 mg/dl * alt and ast no greater than 2.5 times upper limit of normal (uln) (5 times uln if related to liver metastases) renal: * creatinine no greater than 1.5 mg/dl cardiovascular: * no severe symptomatic cardiac disease other: * no clinically significant/evident retinopathy * no other malignancy within the past 5 years except localized nonmelanoma skin cancer or carcinoma in situ of the cervix * no uncontrolled infection * no other significant medical or psychiatric condition that would increase risk * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception for 1 month before, during, and for at least 2 months after study prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics * no prior paclitaxel, cisplatin, or fenretinide * at least 4 weeks since other prior chemotherapy endocrine therapy: * not specified radiotherapy: * see disease characteristics * at least 4 weeks since prior radiotherapy to only site of measurable/evaluable disease * no prior radiotherapy to more than 25% of bone marrow surgery: * at least 2 weeks since prior therapeutic surgery and recovered other: * at least 4 weeks since prior routine vitamin a of at least 10,000 iu/ day or beta carotene of at least 10 mg/day

Keywords: unspecified adult solid tumor, protocol specific